Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML

NCT04842604 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: B1371019 Open Label Extension2017-002822-19
• Study Type: interventional
• Target: 14
• Locations: 11 countries
• Sites: 18

Brief Summary

An open-label study available to all eligible participants from Study B1371019 and participants originating from Study B1371012 continuing on study intervention with azacitidine with or without glasdegib.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment Emergent Adverse Event (AE) and Treatment Related AE

  AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An AE was considered treatment emergent if the event occurred during the on-treatment period (regardless of if it was seen prior to the start of treatment). An AE was considered treatment related as assigned by the investigator.

  From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days)

• Number of Participants With Treatment Emergent Serious Adverse Events (SAE) and Treatment Related SAEs

  A SAE was defined as any untoward medical occurrence that, at any dose that resulted in death; was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or other medical events as per investigator's judgement. A SAE was considered treatment emergent if the event occurred during the on-treatment period (regardless of if it was seen prior to the start of treatment). A SAE was considered treatment related as assigned by the investigator.

  From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days)

Study Arms (1)

Participants from B1371019 and B1371012

EXPERIMENTAL

Azacitidine will be administered 75 mg/m2/day for 7 days every 28 days on Days 1-7 (±3 days) per local label or per the IP Manual (or SPC). Azacitidine may be administered by SC injection or IV infusion. Alternate dosing schedules to administer the 7 doses to accommodate participant and treatment center availability are allowed. The starting dose regimen will be the same as the most recent regimen received on the B1371019 or B1371012 study. Glasdegib 50, 75 or 100 mg will be orally administered daily and continuously. The starting dose regimen will be the same as the most recent regimen received on the B1371012 or B1371019 study.

Drug: Glasdegib; Drug: Azacitidine

Interventions

Glasdegib DRUG

25 mg or 100 mg tablet

Also known as: PF-04449913

Participants from B1371019 and B1371012

Azacitidine DRUG

100 mg/vial powder for 25 mg/mL suspension for injection

Participants from B1371019 and B1371012

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any participant who continues to demonstrate clinical benefit (as determined by the Principal Investigator) from study treatment with azacitidine with or without glasdegib in this Study or from Study B1371012.
• Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

You may not qualify if:

• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Female participants who are pregnant or breastfeeding (if continuing to receive study intervention);
• Participant has been withdrawn from Study B1371019 and Study B1371012 for any reason (including INT cohort participants required to end study treatment)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (18)

Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU

Salzburg, 5020, Austria

Location

Uniklinikum Salzburg, Landeskrankenhaus Salzburg

Salzburg, 5020, Austria

Location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Ustavni lekarna

Ostrava - Poruba, 708 52, Czechia

Location

Klinika hematoonkologie

Ostrava-Poruba, 708 52, Czechia

Location

CHU de Nantes Hotel Dieu

Nantes, 44093, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek

Debrecen, 4032, Hungary

Location

Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika

Debrecen, 4032, Hungary

Location

AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia

Torrette Di Ancona, Ancona, 60126, Italy

Location

SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi

Torette Di Ancona, AN, 60126, Italy

Location

University of Fukui Hospital

Yoshida-gun, Fukui, 910-1193, Japan

Location

Osaka City University Hospital

Osaka, Osaka, 545-8586, Japan

Location

Instituto Nacional de Cancerología

México, MÉX, 14080, Mexico

Location

WWCOiT im. M. Kopemlka w Lodzl

Lodz, 93-513, Poland

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

The Royal Marsden NHS Foundation Trust

Sutton, Surry, SM2 5PT, United Kingdom

Location

Related Links

• B1371019 (NCT03416179)

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic

Interventions

glasdegib; Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: May 17, 2021
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: December 18, 2023
• Results First Posted: December 18, 2023

Record last verified: 2023-11

Locations

IT (2); CA (2); CZ (2); ME (1); HU (2); PL (1); GB (1); ES (1); FR (2); JP (2); AU (2)